MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR GRASPING DEVICE

Model Number	00711177
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch (b)(4), "while attempting to remove food lodged in esophagus with the raptor grasping device, the wire connecting the grasp broke.Food bolus was eventually dislodged with another piece of equipment." no report of injury.
Additional Manufacturer Narrative
The lot number for the raptor grasping device subject of the reported event was not provided in the medwatch (b)(4) report.Steris has made multiple attempts to obtain additional event information from the user facility however, the user facility has not responded.As the lot number was not provided in the medwatch report and the raptor grasping device was not returned, a device history record cannot be reviewed and a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: RAPTOR GRASPING DEVICE
• Common Device Name: RAPTOR GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 18400663
• Report Number: 1528319-2023-00050
• Device Sequence Number: 14114941
• Product Code: OCZ
• UDI-Device Identifier: 00816765011317
• UDI-Public: 00816765011317
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown